MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number WB91051W

Device Problem No Device Output (1435)

Patient Problem Blood Loss (2597)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

The generator was returned to olympus for evaluation.The evaluation did not duplicate the user¿s experience, as the device passed the entire functional tests, electrical, and all outputs are within the standard specification.The unit was tested further using a bovie adapter (maj-619).All coag outputs were within standard upon each activation of the unit.Additionally, the bovie connector was visually checked inside the unit and was found to have no abnormalities on the appearance.However, there were minor scratches noted on the top cover, and minor scratches and dents on the front panel.The generator was returned to the user facility.

Event Description

It was reported that in the middle of a laparoscopic cholecystectomy the generator provided no output and the user experienced difficulty cauterizing a bleeder.The intended procedure was completed using a different generator (model/manufacturer unknown) and a 15 minutes delay was reported.A moderate blood loss was reported.The bleeder was treated by using pressure and surgicel.No further medical intervention was provided, and the patient was discharged home the day of the procedure.

Manufacturer Narrative

This report is being updated to provide investigation results.New information is reported in h4, h6, and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Conclusion: the definitive cause of the reported events could not be established.There are several possible causes that can lead to an insufficient output.These include: 1) a defective cable connection to the instrument.2) a defective hand instrument.3) adherent tissue on the hand instrument.4) if a monopolar mode was used: an improperly connected neutral electrode and/or defective connection to this neutral electrode.Additionally, the electrical conditions in the operating field can also be the cause.In many cases, it is helpful to gradually increase the output level until the desired result is achieved.A defect in the generator can also be a possible cause.However, based on the information available, no direct cause can be attributed to the reported issue.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10614086
• MDR Text Key: 214537082
• Report Number: 9610773-2020-00231
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K141225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Device Lot Number: B006710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 111